Justiciable Controversy Existed for a Generic’s DJ Action on a Patent Listed in the FDA’s Orange Book Even Though the Patent Had Been Disclaimed

April 6, 2015

Federal Circuit reverses dismissal of declaratory judgment action by second ANDA-filer (Apotex) and reverses denial of motion to intervene by first ANDA-filer (Mylan).

Daiichi listed two patents in the Orange Book related to its approved drug. In a prior action against Mylan, Daiichi obtained a judgment of infringement and validity on one patent but disclaimed the second, later-expiring patent after receiving Mylan’s paragraph IV certification alleging it was not infringed and invalid. Apotex then filed an ANDA, made a paragraph III certification that it would not launch before the first patent expired, but sought a declaratory judgment the disclaimed patent was not infringed.

Intervention: Mylan had a right to intervene because, under various Hatch-Waxman Act provisions, the outcome of this litigation could impact whether Mylan, as the first ANDA-filer, was still entitled to a 180-day period of initial marketing exclusivity, or whether the results of this litigation might cause it to forfeit that right.

DJ Jurisdiction: Apotex’s claim against Daiichi met the Article III standards for concreteness, causation, and redressability. Apotex was seeking to obtain concrete relief in this suit because, if successful, it would remove one barrier to its ability to launch its product, and a potential launch had monetary stakes for Apotex, Daiichi, and Mylan. Daiichi’s disclaimer of the patent did not eliminate a concrete controversy because the patent was still listed in the Orange Book, which required Apotex to bring this suit to launch. Moreover, the alleged harm to Apotex was traceable to Daiichi because Daiichi had asked the FDA to list the patent in the Orange Book. Daiichi was thus causally responsible for the alleged harm, regardless of whether its initial listing was proper. Likewise, Apotex’s lack of tentative FDA approval did not render the possibility of Apotex’s relief too uncertain: the Hatch-Waxman Act contemplates litigation by both the patent owner and the ANDA applicant well before tentative approval, and Federal Circuit case law reflects that understanding.

Finally, this action would redress Apotex’s injury because a victory would likely allow it to launch its product sooner. Although Apotex was also blocked from entering the market by Mylan’s 180-day exclusivity, it could trigger a forfeiture of that period by obtaining the non-infringement judgment here and tentative approval of its product. There was no reason to require Apotex to obtain tentative approval before filing this action. The statute imposed no timing requirement that would force Apotex to obtain tentative approval before bringing this suit, so it was free to try to remove both barriers in parallel.

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Craig Countryman is a Principal in the Southern California office of Fish & Richardson and was named a 2016 Rising Star by Law360, was named to the “Top 40 Under 40” lists in both the Daily Journal and the San Diego Daily Transcript, and was distinguished as a...